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A New Poisson and Bayesian-Based Method to Assign Risk and Causality in Patients with Suspected Hepatic Adverse Drug Reactions: A Report of Two New Cases of Ticlopidine-Induced Hepatotoxicity

Zapater, Pedro, Such, Jos??, P??rez-Mateo, Miguel, Horga, Jos?? Francisco·2002·Drug Safety
DOI 10.2165/00002018-200225100-00006
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Abstract

Objective The diagnosis of drug-induced hepatotoxicity is based on circumstantial evidence and is often inaccurate. We have designed a method based on published data to assign causality to suspected cases of drug-induced hepatotoxicity. Design Forty-seven published cases of ticlopidine-induced hepatotoxicity were identified by a Medline-based literature search. Data regarding abnormal liver function in patients receiving ticlopidine were obtained from the only published placebo-ticlopidine clinical trial (the Canadian American Ticlopidine Study; CATS). Thus, we calculated the maximum number of expected hepatotoxicity cases in patients exposed to ticlopidine and those not exposed to the drug by means of the Poisson distribution. The calculated odds ratio was used as a prior odd for subsequent quantification, using a Bayesian-based approach, of individual ticlopidine-induced hepatotoxicity likelihood. Concretely, the prior odd is modified by several separate likelihood ratios: age; sex; AST level; ALT level; alkaline phosphatase level; total bilirubin level; latent period of adverse reaction appearance; and period of remission of adverse reaction. This methodology was applied to two new cases of suspected ticlopidine-induced hepatotoxicity. Results The prior probability of ticlopidine-induced hepatotoxicity derived from CATS data is 61.29%. This is in contrast with the 28.83% incidence rate of drug-induced liver alterations in the general population. Alkaline phosphatase levels…

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  • Probabilistic methods are limited in DILI scenarios by the need for accurate data from a large cohort of cases and by the lack of methodological evaluation specific to hepatic adverse drug reactions.

    “Despite the exploration of probabilistic methods in the context of hepatotoxicity, the need for accurate data derived from a large cohort of cases to model the probability distribution relevant to each parameter, coupled with the lack of methodological evaluation specific to hepatic adverse drug reactions (ADRs), limits the practicality of this modality in DILI scenarios.”

    From Methods for causality assessment of idiosyncratic drug‐induced liver injury (2025) · cites this paper as [22]

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Metadata

Authors
Zapater, P., Such, J., P??rez-Mateo, M., & Horga, J. F.
Venue
Drug Safety
Publisher
Springer Science and Business Media LLC
Published
2002
Volume
25
Issue
10
Pages
735-750
ISSN
0114-5916
DOI
10.2165/00002018-200225100-00006
Cited by
18
References
1
Language
en

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